teriflunomide (Aubagio)

Brand Names: Aubagio

Generic Name: teriflunomide

• What is teriflunomide (Aubagio)?
• What are the possible side effects of teriflunomide (Aubagio)?
• What is the most important information I should know about teriflunomide (Aubagio)?
• What should I discuss with my healthcare provider before taking teriflunomide (Aubagio)?
• How should I take teriflunomide (Aubagio)?
• What happens if I miss a dose (Aubagio)?
• What happens if I overdose (Aubagio)?
• What should I avoid while taking teriflunomide (Aubagio)?
• What other drugs will affect teriflunomide (Aubagio)?
• Where can I get more information (Aubagio)?

Teriflunomide is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Teriflunomide may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using teriflunomide and call your doctor at once if you have:

• numbness or tingling in your hands or feet that feels different from your MS symptoms;
• trouble breathing, new or worsening cough with or without fever;
• signs of infection--fever, chills, body aches, nausea, vomiting, feeling tired; or
• liver problems--upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• headache;
• nausea, diarrhea;
• thinning hair; or
• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not use teriflunomide if you are pregnant or may become pregnant. You will need to have a negative pregnancy test before starting this treatment.

Teriflunomide can cause severe liver problems. You should not use this medicine if you have severe liver disease or if you are also taking leflunomide (Arava). Tell your doctor if you have a history of liver disease.

Call your doctor at once if you have signs of liver problems: upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Your doctor may need to test your liver function up to 6 months before you start taking teriflunomide, and then every month when you first start taking this medicine.

You should not use this medicine if you are allergic to teriflunomide or leflunomide, or if:

• you have severe liver disease; or
• you are also taking leflunomide (Arava).

Do not use teriflunomide if you are pregnant or may become pregnant You will need to have a negative pregnancy test before starting this treatment. Avoid getting pregnant until after you stop taking teriflunomide and undergo a "drug elimination" procedure to help rid your body of this medicine. Stop taking teriflunomide and call your doctor right away if you miss a period or think you might be pregnant.

Tell your doctor if you have ever had:

• liver or kidney disease;
• high blood sugar;
• high blood pressure;
• skin problems when taking medicines;
• a fever, or uncontrolled infections;
• breathing problems;
• tuberculosis; or
• nerve problems, such as neuropathy.

Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking teriflunomide, continue using birth control until you have received blood tests to make sure the drug has been eliminated from your body.

If you become pregnant while taking teriflunomide or within 2 years after you stop, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of teriflunomide on the baby.

If you are a man, use effective birth control to prevent pregnancy if your sex partner is able to get pregnant. After your treatment ends, keep using birth control until you have received the medications to help your body eliminate teriflunomide.

You should not breastfeed while using this medicine.

Before you start treatment with teriflunomide, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take teriflunomide with or without food.

Your blood pressure will need to be checked often.

Teriflunomide can lower your blood cell counts. Your blood will need to be tested often. Your teriflunomide treatment may be delayed based on the results.

After you stop taking teriflunomide, you may need to be treated with other medicines to help your body eliminate teriflunomide quickly. If you do not undergo this drug elimination procedure, teriflunomide could stay in your body for up to 2 years. Follow your doctor's instructions.

You will also need to go through this drug elimination procedure if you plan to become pregnant after you stop taking teriflunomide.

Store at room temperature away from moisture and heat.

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Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using teriflunomide, and for at least 6 months after you stop taking it. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can affect teriflunomide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about teriflunomide.

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